METHOD AND APPARATUS FOR THE DELIVERY OF PHOTOCHEMICAL (CROSS-LINKING) TREATMENT TO SCLERAL TISSUE

• US 20120209051A1
• Filed: 02/14/2012
• Published: 08/16/2012
• Est. Priority Date: 02/15/2011
• Status: Active Grant

• Current Assignee: ALeyeGN Technologies LLC
• Original Assignee: Seros Medical, LLC
• Inventors: Blumenkranz, Mark S., Manche, Edward E., Herekar, Satish V., Eaton, Donald J.
• Granted Patent: US 9,005,099 B2
• Time in Patent Office: Days
• US Class Current: 600/2
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0079 using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 41/0038 Radiosensitizing, i.e. administration of pharmaceutical agents that enhance the effect of radiotherapy radiotherapy per se A61N5/10
• CPC Class Codes: A61K 41/0057 Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Delivery systems and methods for delivering riboflavin (R/F) and UVA irradiation to the sclera are disclosed. The R/F is delivered and then activated with UVA irradiation through the use of LEDs or optical fibers, thereby causing cross-linking of the collagen tissue. Delivery systems include implantable structures which provide surfaces that conform to the sclera. The delivery systems include various types of structures for delivery of R/F onto the sclera surface. Additionally, the delivery systems include UVA sources which provide irradiation of R/F in sclera collagen tissue.

Claims

1. A method of treating ocular tissue comprising:

providing an apparatus that upon insertion will deliver a drug formulation comprising riboflavin to scleral ocular tissue of a sclera;

inserting the apparatus through an opening in a conjunctiva to deliver the drug formulation to targeted regions of the scleral ocular tissue; and

allowing the drug formulation to diffuse from the apparatus into the targeted regions of the scleral tissue to soak the scleral tissue,

wherein the drug formulation comprises riboflavin which is capable of being activated by UVA irradiation for purposes of inducing cross-linking of scleral collagen tissue.

2. The method of claim 1, wherein the apparatus is disposed in an equatorial region on the sclera and under four rectus muscles of the sclera.

3. The method of claim 1, wherein the apparatus is disposed in an anterior segment of the sclera.

4. The method of claim 1, wherein the apparatus is disposed in a posterior segment of the sclera.

5. The method of claim 1, wherein the apparatus contains channels for delivering the drug formulation onto a surface of the sclera, and thereby enabling the riboflavin to soak into collagen tissue of the sclera.

6. The method of claim 1, wherein the apparatus includes a system to rinse excess drug formulation from the scleral surface after soaking.

7. The method of claim 1, further comprising delivering UVA irradiation to the targeted regions of the scleral tissue to cross-link scleral collagen tissue exposed to the delivered formulation.

8. A method of treating ocular tissue comprising:

providing a mat containing a sponge comprising a source of riboflavin;

disposing the mat through an opening in the conjunctiva; and

soaking targeted regions of scleral tissue with riboflavin from the source through application of the sponge on the scleral tissue.

9. The method of claim 8, wherein the sponge is inserted onto the sclera around its equator and under the four rectus muscles or the sponge is inserted onto the sclera in one or more of four quadrants between the four rectus muscles.

10. The method of claim 8, wherein the sponge is inserted onto a posterior portion of the sclera.

11. The method of claim 8, wherein the sponge is inserted onto an anterior portion of the sclera.

14. The method of claim 11, wherein the source is LEDs or optical fibers that deliver the UVA irradiation.

15. The method of claim 14, wherein the LEDs in the mat are cooled by instilling a coolant solution in channels within the mat.

16. The method of claim 11, wherein the mat is inserted onto the sclera around its equator and under the four rectus muscles or the mat is inserted onto the sclera in one or more of four quadrants between the four rectus muscles.

12. A method of treating ocular tissue comprising:

providing a mat comprising a source of UVA irradiation;

disposing the mat through an opening in the conjunctiva; and

irradiating targeted regions of scleral tissue with UVA irradiation from the UVA source.

13. The method of claim 12, wherein the targeted regions of scleral tissue comprise those regions which have been soaked with riboflavin and the irradiation induces cross-linking of the irradiated tissue.

17. The method of claim 12, wherein the mat is inserted onto a posterior portion of the sclera.

18. The method of claim 12, wherein the mat is inserted onto an anterior portion of the sclera.

19. A system for treatment of the equatorial region of the sclera comprising:

a cylindrical belt-like apparatus having an outer convex surface and an inner convex surface, wherein the apparatus is shaped so that the inner concave surface conforms to an equatorial region of a sclera of an eye when disposed around the equatorial region;

channels within the apparatus for transporting and delivering R/F fluid to the sclera surface of the equatorial region of the sclera of an eye or no channels for transporting R/F fluid within the apparatus; and

UVA sources embedded in the inner concave surface of the section for delivering UVA irradiation to the to the sclera surface of the equatorial region of the sclera of an eye exposed to R/F fluid.

20. The system of claim 19, wherein the apparatus is shaped and sized to be inserted around the equatorial region of the sclera and beneath the four rectus muscles of the sclera and applied to the surface of the sclera.

21. The system of claim 19, wherein the apparatus has a slit in its wall extending longitudinally along its entire length from the top end to the bottom end forming two ends, wherein the ends are joined in use to seal the apparatus.

22. A system for treatment of the posterior region of the sclera comprising:

an R/F applicator comprising a R/F sponge-mat having a concave porous surface for absorbing and delivering R/F fluid to a surface of the posterior segment of the sclera, wherein the R/F mat is sized to be inserted to the posterior segment of the sclera, wherein the concave surface is shaped to conform to a surface of the posterior segment of the sclera; and

a UVA applicator comprising UVA mat having a concave surface including UVA sources attached or embedded in the concave surface of the U/VA mat for delivering UVA irradiation to a surface of the posterior segment of the sclera upon removal of the R/F applicator, wherein the UVA applicator is sized to be inserted onto the posterior segment of the sclera, wherein the concave surface is shaped to conform to a surface of the posterior segment of the sclera.

23. The system of claim 22, wherein the R/F applicator further comprises a handle attached to the R/F sponge-mat to facilitate its insertion to the posterior region of the sclera.

24. The system of claim 22, wherein the handle comprises a channel that connects a port at one end of the handle for injection of the R/F fluid to the R/F sponge-mat and the porous surface.

25. The system of claim 22, wherein the UVA sources comprise LEDs to provide UVA irradiation of the R/F that has soaked into the sclera, wherein a protective cover over the LEDs creates a barrier between the LEDs and the sclera surface upon insertion of the UVA applicator onto the posterior segment of the sclera.

26. A system for treatment of the anterior region of the sclera comprising:

an annular R/F applicator comprising an inner circular surface around a hole, an outer circular surface, a top surface, and a bottom surface, wherein the bottom surface has an inward radial curvature so that bottom surface conforms to the surface of an anterior region of the sclera when the annular R/F applicator is placed on the anterior region, wherein the hole allows the R/F applicator to avoid contact with the cornea, wherein channels embedded in the applicator allow delivery of R/F fluid to the anterior segment of the sclera when the R/F applicator is placed on the anterior segment of sclera; and

an annular UVA applicator comprising an inner circular surface around a hole, an outer circular surface, a top surface, and a bottom surface, wherein the bottom surface has an inward radial curvature so that bottom surface conforms to the surface of an anterior region of the sclera when the annular R/F applicator is placed on the anterior region, wherein the hole allows the UVA applicator to avoid contact with the cornea, wherein UVA sources are attached or embedded in the bottom surface of the UVA applicator for delivering of UVA irradiation to a surface of the anterior segment of the sclera upon removal of the R/F applicator.

27. The system of claim 26, wherein the R/F applicator comprises a port connected to the channels for delivery of the R/F fluid.

28. The system of claim 26, wherein UVA source is comprised of LEDs, wherein a protective cover over the LEDs creates a barrier between the LEDs and the surface of the sclera upon insertion of the UVA applicator on the anterior segment of the sclera.